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Session 8, Tracks C: Exploring Different Pharmacovigilance Methods to Strengthen Post-Market Monitoring
Session Chair(s)
Bianca Passos, MBA, RPh
Country Safety Head - Brazil
Sanofi, Brazil
Rosana M. Mastellaro, PharmD, RPh
Director, Technical Regulatory Affairs and Inovation
Sindusfarma, Brazil
This session will analyze the importance of safety surveillance to enhance safety signal detection and monitor the effectiveness of risk minimization strategies, in a growing data volume context. Attendees will also explore the adoption of different pharmacovigilance (PV) methods according to the risk to be evaluated, types of products, and available sources.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize methods used by health programs to monitor the safety of incorporated products
- Discuss the value of different sources of PV data for signal detection and effectiveness measures of risk minimization strategies
- Identify the changes the pandemic has brought concerning sources of data and methods to analyze it
Speaker(s)
ConcePTION: The Use of Multiple Healthcare Databases in Europe for Medication Safety Monitoring in Pregnant Women
Leonardo R. Pereira, PharmD, MSc
Roche, United Kingdom
Clinical Safety Director
Can Electronic Health Records Databases Complement Spontaneous Reporting System Databases in Post-Marketing Monitoring?
Vaishali Patadia, PhD
Amgen, United States
Executive Director, Signal Mgt and Risk Mgt
Strengthening Pharmacovigilance and Adherence to the Malaria Treatment in Brazil
Sheila Rodrigues Rodovalho, PhD, MSc
Pan American Health Organization, Brazil
Technical Officer
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